Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00770458

Enrollment

1000

Registered

2008-10-10

Start date

2008-06-30

Completion date

2009-12-31

Last updated

2010-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome (Trisomy 21), Edwards Syndrome (Trisomy 18), Patau Syndrome (Trisomy 13), Turner Syndrome

Keywords

Down Syndrome

Brief summary

Validate that circulating cell free fetal nucleic acid can be used to identify a direct marker for fetal aneuploidy, particularly fetal Down Syndrome (DS), that is better than surrogate markers.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject is female * Subject is pregnant * Subject is high risk aneuploid patient undergoing genetic counseling, unltrasound screening, amniocentesis and/or CVS procedure * Subject is willing to provide blood specimen

Exclusion criteria

* Subject is not pregnant * Subject is not willing to provide blood specimen * Subject is not haveing aneuploid screening

Design outcomes

Primary

Measure	Time frame
Compare investigational assay results for Down Syndrome to standard of care results.	3 months

Countries

United States

Outcome results